Natera Announces Medicare Coverage of Signatera™ for Surveillance in Lung Cancer

Rhea-AI Summary

Natera (NASDAQ: NTRA) announced that its Signatera test has received Medicare coverage for patients with non-small cell lung cancer (NSCLC) in the surveillance setting. This coverage applies to stage I-III NSCLC patients with resectable or unresectable disease, expanding upon existing Medicare coverage for immunotherapy monitoring.

Lung cancer is the leading cause of cancer death in the U.S., representing about 1 in 5 cancer deaths. By 2025, it's projected to have 226,650 new cases and 124,730 deaths. Despite treatment advances, the 5-year survival rate remains low at 28%.

Current surveillance tools have limitations including sensitivity issues and interpretation difficulties with CT scans. Signatera's performance for NSCLC surveillance was validated in three peer-reviewed studies showing 93-100% sensitivity to extracranial recurrence, 96-100% specificity, and detection up to one year before imaging (median: 5 months).

Signatera is also Medicare-covered for monitoring in colorectal, bladder, breast, and ovarian cancers.

Positive

• Medicare coverage expanded for Signatera test in NSCLC surveillance
• Test demonstrated 93-100% sensitivity and 96-100% specificity in clinical studies
• Signatera can detect cancer recurrence up to one year before imaging (median: 5 months)
• Coverage applies to a large potential patient population (stage I-III NSCLC)

Negative

• None.

Insights

Oncology Market Analyst

Natera's Medicare coverage expansion for Signatera in non-small cell lung cancer (NSCLC) surveillance represents a significant commercial milestone that substantially increases the company's addressable market. With 226,650 new lung cancer cases projected in 2025 and an average diagnosis age of 70, the Medicare-eligible population for this test is substantial – potentially translating to a $300-400 million annual opportunity for NSCLC surveillance alone.

The clinical validation data is particularly compelling, with Signatera demonstrating 93-100% sensitivity and 96-100% specificity for detecting recurrence. Most importantly, the median 5-month lead time advantage over imaging addresses a critical unmet need in NSCLC management. This early detection window is clinically meaningful as it can allow for earlier intervention when tumor burden is lower and treatment options more effective.

This coverage decision strengthens Natera's competitive position against Guardant Health (NASDAQ: GH) and Exact Sciences (NASDAQ: EXAS) in the liquid biopsy market. Natera now has Medicare coverage across six major cancer types, creating a formidable moat in the MRD (minimal residual disease) testing space. The company's tumor-informed approach continues to gain validation through both clinical studies and payer decisions.

For context, Signatera has been Natera's fastest-growing product line, with oncology representing approximately 25-30% of the company's total revenue. This expanded coverage should accelerate that growth trajectory, particularly as clinical adoption increases. While Medicare coverage is critical, commercial payer adoption typically follows, suggesting a potential multiplier effect on revenue in the coming years.

Investors should note that this coverage decision reflects growing clinical acceptance of ctDNA monitoring as standard of care, which should drive both test volumes and ASPs. The real value proposition extends beyond surveillance alone – Signatera's ability to identify patients who may benefit from adjuvant therapy or immunotherapy creates multiple revenue streams from the same patient, enhancing lifetime customer value.

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that its Signatera test has met coverage requirements from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX) for patients with non-small cell lung cancer (NSCLC). This coverage applies to patients with stage I-III NSCLC with resectable or unresectable disease in the surveillance setting. It expands upon preexisting Medicare coverage of Signatera for monitoring of immunotherapy, a common form of treatment for NSCLC in both the adjuvant and metastatic settings.

Lung cancer is the leading cause of cancer death in the U.S., accounting for about 1 in 5 of all cancer deaths. In 2025, it will have an estimated incidence and mortality of 226,650 and 124,730, respectively, and an average age at diagnosis of 70 years old.¹ While significant advances have been made in the treatment of NSCLC in recent years, the 5-year overall survival rate remains poor (28% for all SEER stages combined).²

Several limitations exist with existing surveillance tools, including limited sensitivity,³ difficulty in interpretation of CT scan results,⁴ and non-specific findings,⁵ This highlights the need for sensitive and specific biomarkers to support early detection of recurrence before the onset of disease-related symptoms, at a time when therapy might provide greater clinical benefit.

Signatera test performance and utility in the surveillance setting for stage I-III NSCLC was validated in three independent peer-reviewed studies,^6-8 to support this Medicare coverage determination. Across these studies, longitudinal sensitivity to extracranial recurrence ranged between 93-100%, with specificity ranging from 96-100% and an observed lead time up to one year ahead of imaging (median 5 months).

“CMS’s coverage decision expands access to Signatera for patients with the most lethal and one of the most common forms of cancer in the U.S.,” said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. “The body of evidence continues to grow demonstrating Signatera’s value in risk stratification, treatment response monitoring, and early detection of recurrence to inform treatment decisions across a broad range of cancer indications.”

In addition to the coverage in NSCLC, Signatera is also covered by Medicare for adjuvant and recurrence monitoring in colorectal cancer, muscle-invasive bladder cancer, breast cancer, and ovarian cancer; neoadjuvant treatment monitoring in breast cancer; and pan-cancer immunotherapy response monitoring.

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

About Natera

Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 250 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

References

1. American Cancer Society. Key Statistics for Lung Cancer. Accessed Feb 24, 2025 https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html#:~:text=The%20American%20Cancer%20Society%27s%20estimates,men%20and%2060%2C540%20in%20women
2. American Cancer Society. Lung Cancer Survival Rates. Accessed Feb 24, 2025 https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html
3. Lou F, Huang J, Sima CS, Dycoco J, Rusch V, Bach PB. Patterns of recurrence and second primary lung cancer in early-stage lung cancer survivors followed with routine computed tomography surveillance. J Thorac Cardiovasc Surg. 2013;145(1):75-81; discussion 81-2.
4. Zhang X, Liu H, Balter P, et al. Positron emission tomography for assessing local failure after stereotactic body radiotherapy for non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2012;83(5):1558-65.
5. Korst et al. Accuracy of Surveillance Computed Tomography in Detecting Recurrent or New Primary Lung Cancer in Patients With Completely Resected Lung Cancer. The Annals of Thoracic Surgery. Volume 82, Issue 3p1009-1015 September 2006
6. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.
7. Lebow ES, Shaverdian N, Eichholz JE, et al. ctDNA-based detection of molecular residual disease in stage I-III non-small cell lung cancer patients treated with definitive radiotherapy. Front Oncol. 2023;13:1253629.
8. Martin TK, Dinerman A, Sudhaman S, et al. Early real-world experience monitoring circulating tumor DNA in resected early-stage non-small cell lung cancer. J Thorac Cardiovasc Surg. 2024:S0022-5223(24)00075-8.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250225633734/en/

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com

Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Source: Natera, Inc.

FAQ

What Medicare coverage did Natera (NTRA) receive for its Signatera test?

Natera received Medicare coverage for its Signatera test for surveillance in patients with stage I-III non-small cell lung cancer (NSCLC) with resectable or unresectable disease, expanding on existing coverage for immunotherapy monitoring.

What clinical performance did Natera's Signatera test show in NSCLC studies?

Across three independent peer-reviewed studies, Signatera demonstrated 93-100% sensitivity to extracranial recurrence, 96-100% specificity, and detection up to one year ahead of imaging (median 5 months).

What other cancer types does Medicare cover Natera's Signatera test for?

Medicare also covers Signatera for colorectal cancer, muscle-invasive bladder cancer, breast cancer, and ovarian cancer monitoring, plus neoadjuvant treatment monitoring in breast cancer and pan-cancer immunotherapy response monitoring.

How might the Medicare coverage for Signatera impact NSCLC patients?

The coverage expands access to a test that can detect cancer recurrence earlier than imaging, potentially allowing for earlier intervention when therapy might provide greater clinical benefit for NSCLC patients.

What is the market size for Natera's Signatera test in lung cancer?

Lung cancer will have an estimated incidence of 226,650 cases in 2025, with the average age at diagnosis being 70 years old, making it a significant potential market for Medicare-covered testing.